The FDA has reversed course on a decision about Nicotinamide mononucleotide (NMN). After previously allowing its sale, the FDA have determined that NMN cannot be sold in dietary supplements because of its recent approval as an investigational drug.
In the last couple of years multiple peer-reviewed human NMN studies were published establishing the efficacy and safety of NMN. This research opened the door to selling this promising supplement in the U.S. after years of being available in Japan and other countries worldwide. But, this new FDA action throws a wrench into the plans of companies who have rigorously pursued the proper channels to get NMN on the market.
However, due to the lack of coordination of the various FDA departments, FDA has been forced by some drug companies to ban NMN as a dietary supplement. Dietary Supplement trade associations are contemplating their next moves, possibly petitioning the FDA to change its mind, or filing suit.
For the time being, NMN remains on the shelves because the FDA has not threatened any seizures. However, we don’t know how long this “truce” will last. What we do know is that there are no safety issues with the NMN as sold by Momentous, and the reason it is being reviewed now by FDA is due to technical legal issues. We have a limited number of NMN still available for sale, however the product will be discontinued in the near future.
What exactly is NMN?
For those unfamiliar with NMN, it's a nucleotide found in all living cells. It is a critical component of energy metabolism in the body. However, it's thought the real power of NMN is as the immediate precursor to an essential coenzyme called nicotinamide adenine dinucleotide (NAD+). NAD+ is required for all life and cellular functions. It's so critical that if NAD+ levels in your body drop to zero, you'd be dead in about 30 seconds.
Researchers have found that our NAD+ levels at age 50 are about half what they were when we were (1). Those plummeting NAD+ levels are what many researchers believe are the leading cause of all sorts of age-related declines (2). NAD+ is vital for turning nutrients into cellular energy, keeping your DNA healthy, activating anti-aging sirtuins, and hundreds of other metabolic processes. While we all get some NAD+ in our bodies through a regular diet consisting of its precursors, one can't physically eat enough of anything to boost NAD+ levels significantly.
That's where an NMN supplement can help mitigate the inevitable NAD+ decline.
1 Massudi, H., Grant, R., Braidy, N., Guest, J., Farnsworth, B., & Guillemin, G. J. (2012). Age-Associated Changes In Oxidative Stress and NAD+ Metabolism In Human Tissue. In M. Polymenis (Ed.), PLoS ONE (Vol. 7, Issue 7, p. e42357). Public Library of Science (PLoS). https://doi.org/10.1371/journal.pone.0042357
2 Chini, C. C. S., Tarragó, M. G., & Chini, E. N. (2017). NAD and the aging process: Role in life, death and everything in between. In Molecular and Cellular Endocrinology (Vol. 455, pp. 62–74). Elsevier BV. https://doi.org/10.1016/j.mce.2016.11.003